Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY110140 · 1 trial · 1 indication
A drug-related AE was an AE that occurred postdose or was present predose and became more severe postdose and was considered to be related to study treatment. A summary of AEs, regardless of causality, is located in the Reported Adverse Events module.
A drug-related AE was an AE that occurred postdose or was present predose and became more severe postdose and was considered to be related to study treatment. A summary of AEs, regardless of causality, is located in the Reported Adverse Events module.
| Arm | Type | Description |
|---|---|---|
| 5 milligrams (mg) LY110140 (SD) | EXPERIMENTAL | 5 mg administered once in the fasted state on Day 1 |
| 20 mg LY110140 (SD) | EXPERIMENTAL | 20 mg administered once in the fasted state on Day 1 |
| 40 mg LY110140 (SD) | EXPERIMENTAL | 40 mg administered once in the fasted state on Day 1 |
| Placebo (MD) | PLACEBO_COMPARATOR | Placebo once daily oral dosing for 28 consecutive days |
| 20 mg LY110140 (MD) | EXPERIMENTAL | 20 mg once daily oral dosing for 28 consecutive days |
| 40 mg LY110140 (MD) | EXPERIMENTAL | 40 mg once daily oral dosing for 28 consecutive days |
| Name | Type | Description |
|---|---|---|
| LY110140 | DRUG | Administered orally as capsules |
| Placebo | DRUG | Administered orally as capsules in the placebo arm and to maintain the blind in the 20 mg LY110140 (MD) arm |
Inclusion Criteria: * Overtly healthy Japanese males (as determined by medical history and physical examination) who agree to use a reliable method of birth control during the study and for 3 months following the last dose of the investigational product. * Have a body mass index (BMI) of 18.5 to 29...
LY110140 is an investigational small molecule being studied in healthy volunteers. It is not approved for any disease and is in early clinical development. The completed Phase 1 trial enrolled healthy Japanese male participants to evaluate the drug's safety and tolerability.
LY110140 is being developed by Eli Lilly and Company (NYSE: LLY). The company sponsored a Phase 1 clinical trial of the drug in healthy volunteers.
LY110140 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A single Phase 1 trial has been completed.
LY110140 has one completed clinical trial, NCT01569126, titled "A Study of LY110140 in Healthy Japanese Male Participants." The trial was a randomized, double-blind, placebo-controlled study that enrolled 56 participants in Japan.
LY110140 is the drug name used in clinical trial records. No alternative names have been reported for this investigational small molecule.